Drug Companies Refuse to Produce Generic, Less-Profitable Anti-Cancer Drug, Leading to Recurrence of Lymphoma. This is a particularly eloquent illustration of the deadly effects of production for profits, rather than production for our needs. It also illustrates how the capitalists’ ownership of intellectual property (drug patents, in this case) is as toxic as their ownership of the factories, farms, hospitals etc, where we have to work to earn the money to buy back what we make in these places of employment. Bear in mind that the government pays for 80% of the research on drugs which the pharmacy companies then get patents on.

A drug given to lymphoma patients as a substitute for a chemotherapy medication that is in short supply has been linked in a study to an early recurrence of the cancer, according to a report released Wednesday that provides the first actual evidence of patient harm caused by a national shortage of drugs.

The shortage specifically includes older, generic medications needed for a wide range of uses such as cancer, surgery and pain management, say authors of the report, which involved Stanford University School of Medicine and Lucile Packard Children’s Hospital in Palo Alto.

“These are drugs that have gone off patent a long time ago. They are drugs that are all generic and they are quite cheap, so there’s not much incentive for the manufacturers to make them,” said Dr. Michael Link, professor of pediatrics at Stanford’s School of Medicine and senior author of the report.

Drug shortages throughout the country have been attributed to various factors, including problems in production, difficulties in getting raw materials, federal recalls and enforcement actions, and corporate decisions to discontinue making certain medications for lack of profit or other reasons.

From 2006 to 2011, the number of pharmaceutical drugs considered in short supply by the U.S. Food and Drug Administration jumped from 70 to 250. Some reports show that the drug shortage rate has slowed, but some drugs that at one point came off the short-supply list are in short supply once again, and many drugs have consistently remained scarce.

Behind the report

Wednesday’s report, led by researchers at St. Jude Children’s Research Hospital in Memphis and published in the New England Journal of Medicine, looked at more than 200 children, teenagers and young adults who had been enrolled in an ongoing national clinical trial to treat intermediate or high-risk Hodgkin’s lymphoma. This type of cancer, which accounts for about 6 percent of childhood cancers, originates from white blood cells called lymphocytes.

The trial focused on tailoring radiation therapy for patients, but had to be modified when one of the drugs used in the trial – an injectable drug called mechlorethamine, also known as Mustargen or nitrogen mustard – became unavailable in 2009. The shortage, brought on when production was moved to a new plant, forced researchers to replace mechlorethamine with a decades-old chemotherapy drug called cyclophosphamide, or Cytoxan.

Because cyclophosphamide is used almost interchangeably with mechlorethamine, researchers were not expecting much of a difference in outcomes for the patients, but while none of the patients died, the percentage of patients who remained cancer free two years after treatment fell from 88 to 75 percent.

“We were totally blindsided by the results,” Link said.

Study results end trial

Those who relapsed had to receive additional intensive therapy, which is associated with higher odds for infertility and other health problems. Researchers stopped enrolling new patients in the trials once the negative results from the substitute became apparent. The drug shortage was resolved in early November.

Hospital administrators, pharmacists and doctors have routinely found alternative medications when a preferred drug became hard to come by. But Link said his fellow physicians have long suspected that patients were being harmed by these substitutions.

The national drug shortage prompted new federal legislation this summer that requires drug manufacturers to report production interruptions and gives the FDA authority to speed approval of applications for drugs in short supply.

Maria Serpa, senior pharmacist at Sutter Medical Center in Sacramento and former president of the California Society of Health-System Pharmacists who was not involved in the St. Jude study, wasn’t surprised that the results showed patients were being harmed by the inability to get certain drugs. She said she regularly sees shortages of various drugs such as those used in anesthesia and to control pain.

“I don’t think the list is getting any smaller,” Serpa said, referring to the FDA’s shortage list. “What’s frustrating is the re-emergence of some of the older shortages from two or three years ago. This just seems to keep coming back.”